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Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00097071

First Posted: November 18, 2004

Last Update Posted: December 22, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Novo Nordisk A/S

Purpose

This trial is conducted in the United States of America (USA). It is demonstrated that intensive insulin therapy resulting in good glycaemic control can reduce or delay the incidence of complications secondary to Type 1 Diabetes. Insulin Aspart (NovoLog®) is an ideal insulin to use in an intensive insulin regimen using continuous subcutaneous insulin injection (CSII) therapy in the pediatric and adolescent age population. This trial compares the safety and efficacy of Insulin Aspart (NovoLog®) and Insulin Lispro (Humalog®) delivered by CSII in children and adolescents with type 1 diabetes.

Condition	Intervention	Phase
Diabetes Diabetes Mellitus, Type 1	Drug: insulin lispro Drug: insulin aspart	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Safety and Efficacy of Insulin Aspart Versus Insulin Lispro in Insulin Pumps in Children and Adolescents With Type 1 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Type 1

Drug Information available for: Insulin Insulin human Insulin aspart Insulin lispro

U.S. FDA Resources

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:

HbA1c [ Time Frame: After 16 weeks treatment ]

Secondary Outcome Measures:

Measurements of glycaemic control, safety parameters including frequency of hypoglycaemia, laboratory tests, clinical evaluations and adverse events


Enrollment:	299
Study Start Date:	October 2004
Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	3 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 1 Diabetes

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097071

Hide Study Locations

Locations


United States, Alabama
Novo Nordisk Investigational Site
Mobile, Alabama, United States, 36617
Novo Nordisk Investigational Site
Montgomery, Alabama, United States, 36106
United States, Arizona
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85016
United States, Arkansas
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States, 72202
United States, California
Novo Nordisk Investigational Site
Loma Linda, California, United States, 92354
Novo Nordisk Investigational Site
Sacramento, California, United States, 95816
Novo Nordisk Investigational Site
San Diego, California, United States, 92123
United States, Colorado
Novo Nordisk Investigational Site
Denver, Colorado, United States, 80262
Novo Nordisk Investigational Site
Englewood, Colorado, United States, 80110
United States, Connecticut
Novo Nordisk Investigational Site
New Haven, Connecticut, United States, 06520
United States, Florida
Novo Nordisk Investigational Site
Orlando, Florida, United States, 32806-1101
Novo Nordisk Investigational Site
St. Petersburg, Florida, United States, 33701
Novo Nordisk Investigational Site
Tallahassee, Florida, United States, 32308
United States, Georgia
Novo Nordisk Investigational Site
Atlanta, Georgia, United States, 30318
United States, Idaho
Novo Nordisk Investigational Site
Idaho Falls, Idaho, United States, 83404-7596
United States, Indiana
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46202-2879
United States, Iowa
Novo Nordisk Investigational Site
Iowa City, Iowa, United States, 52242
United States, Kansas
Novo Nordisk Investigational Site
Topeka, Kansas, United States, 66606
Novo Nordisk Investigational Site
Wichita, Kansas, United States, 67226
United States, Louisiana
Novo Nordisk Investigational Site
Baton Rouge, Louisiana, United States, 70808
United States, Maryland
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21229
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Novo Nordisk Investigational Site
Boston, Massachusetts, United States, 02115
Novo Nordisk Investigational Site
Boston, Massachusetts, United States, 02215
Novo Nordisk Investigational Site
Springfield, Massachusetts, United States, 01107
Novo Nordisk Investigational Site
Worcester, Massachusetts, United States, 01655
United States, Michigan
Novo Nordisk Investigational Site
Detroit, Michigan, United States, 48202-2689
United States, Minnesota
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States, 55416
Novo Nordisk Investigational Site
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Novo Nordisk Investigational Site
Kansas City, Missouri, United States, 64108
United States, Nebraska
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68114
Novo Nordisk Investigational Site
Omaha, Nebraska, United States, 68198-3020
United States, New Jersey
Novo Nordisk Investigational Site
Hackensack, New Jersey, United States, 07601
United States, New York
Novo Nordisk Investigational Site
Bronx, New York, United States, 10467
Novo Nordisk Investigational Site
Brooklyn, New York, United States, 11219
Novo Nordisk Investigational Site
Buffalo, New York, United States, 14222
Novo Nordisk Investigational Site
Manhasset, New York, United States, 11030
United States, North Carolina
Novo Nordisk Investigational Site
Asheville, North Carolina, United States, 28803
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States, 27599-7220
United States, Ohio
Novo Nordisk Investigational Site
Columbus, Ohio, United States, 43203
United States, Oklahoma
Novo Nordisk Investigational Site
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Novo Nordisk Investigational Site
Hershey, Pennsylvania, United States, 17033
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Novo Nordisk Investigational Site
Charleston, South Carolina, United States, 29425
United States, Texas
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78229
Novo Nordisk Investigational Site
San Antonio, Texas, United States, 78284
United States, Virginia
Novo Nordisk Investigational Site
Norfolk, Virginia, United States, 23507
United States, Washington
Novo Nordisk Investigational Site
Seattle, Washington, United States, 98105
United States, West Virginia
Novo Nordisk Investigational Site
Charleston, West Virginia, United States, 25302
United States, Wisconsin
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, United States, 53226-0509

Sponsors and Collaborators

Novo Nordisk A/S

Investigators


Study Director:	Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Publications:

Weinzimer SA, Ternand C, Howard C, Chang CT, Becker DJ, Laffel LM; Insulin Aspart Pediatric Pump Study Group. A randomized trial comparing continuous subcutaneous insulin infusion of insulin aspart versus insulin lispro in children and adolescents with type 1 diabetes. Diabetes Care. 2008 Feb;31(2):210-5. Epub 2007 Nov 5.


Responsible Party:	Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00097071 History of Changes
Other Study ID Numbers:	ANA-2181
First Submitted:	November 17, 2004
First Posted:	November 18, 2004
Last Update Posted:	December 22, 2016
Last Verified:	December 2016

Keywords provided by Novo Nordisk A/S:


Diabetes, Type 1

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases	Insulin, Globin Zinc Insulin Insulin Aspart Insulin Lispro Hypoglycemic Agents Physiological Effects of Drugs

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